Keyter Andrea, Gouws Joey, Salek Sam, Walker Stuart
1 Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
2 Department of Health, Medicines Control Council, South Africa.
Ther Innov Regul Sci. 2018 Jul;52(4):449-458. doi: 10.1177/2168479018776649. Epub 2018 May 30.
The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices.
A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs).
Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future.
As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.
本研究的目的是评估2015年至2017年南非的监管审查流程，确定关键节点和时间线；评估确保审查过程的一致性、透明度、及时性和可预测性的措施的有效性；并为加强监管实践提供建议。
药品控制委员会（MCC）填写了一份调查问卷，以描述该机构的组织架构，记录审查过程中的关键节点和时间线，并确定良好审查实践（GRevPs）。
目前，MCC在审查所有申请时会对质量、疗效和安全性数据进行全面评估。尽管申请数量增加了27%，但2017年的总体监管批准时间中位数（1411个日历日）与2016年相比下降了14%。然而，MCC没有新活性物质申请的总体批准时间目标，也没有关键审查节点的目标。指南、标准操作程序和审查模板已经到位，而GRevPs的正式实施和电子文档管理系统的应用计划在不久的将来进行。
随着MCC向新成立的南非卫生产品监管局过渡，该机构认识到加强监管审查的机会至关重要，应考虑采用简化评估等模式，其中包括风险分层和依赖的要素。希望这样可以缓解资源限制并发展能力以满足目标时间线。
